LYPSYL VANILLA PLUM INTENSE PROTECTION- lip balm lipstick 
Lornamead

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Octyl Methoxycinnamate 5.5%...................................Sunscreen

Octylcrylene 2.0%....................................................Sunscreen

Oxybenzone 3.5%....................................................Sunscreen

Avobenzone 3.0%.....................................................Sunscreen

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea Butter), Ceresin, Euterpe Oleracea (Acai) Fruit Extract, Flavor, Hydrogenated Coconut Oil, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Tocopheryl Acetate

Directions

Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including

Other Information

Protect this product from excessive heat and direct sun.

Use

Helps prevent sunburn

Warnings

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Questions or Comments

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Carton Label

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Cylinder Label

LYPSYL VANILLA PLUM  INTENSE PROTECTION
lip balm lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-8127
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
ACAI (UNII: 46AM2VJ0AW)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPLUM (Vanilla Plum) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62721-8127-82.83 in 1 BLISTER PACK
1NDC:62721-8127-62.83 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2014
Labeler - Lornamead (126440440)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions243501959manufacture(62721-8127) , pack(62721-8127)

Revised: 12/2013
Document Id: 2771ef5a-bde4-46b0-8a8c-d4c5d0b807ed
Set id: 014c36b5-bbb7-4e65-b42e-33a6af197474
Version: 1
Effective Time: 20131213
 
Lornamead